# K122505: Single Use Preloaded Sphincterotome V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Apr 11, 2013 after 238 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910722 (1991). 7 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950166: Olympus KD-6G1-9Q Wire Guided Papillotomu Knife, Olympus America, Inc. (1995) Summary page 1.
- K091417: Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A, Terumo Corp. (2009) Summary page 1.

## Most influential descendants
- K141991: Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP (2015), 4 descendants of its own
- K192339: TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (2020), 1 descendant of its own
- K150142: Single Use Balloon Dilator V (with Knife) (2015), 1 descendant of its own
- K250945: Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (2025), 0 descendants of its own
- K243568: Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (2025), 0 descendants of its own

## Indications for use
These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

Source page: https://510kreport.com/device/K122505
Methodology: https://510kreport.com/methodology